In 2006, an estimated 55,170 people in the United States died from colorectal cancer and 148,650 new cases were diagnosed. According to the National Cancer Institute, colon cancer is the second most deadly cancer in the United States. Of great importance in each case is early and accurate diagnosis, in which case colonoscopy is the standard tool for examination. Colonoscopy screening has been shown to reduce the expected morbidity and mortality of colorectal carcinoma by 76% to 90% (American Cancer Society. Colon and rectal cancer treatment guidelines for patients. Version 1, March 2000, (00-80M-No. 9409-HCP)). The U.S. Centers for Disease Control and Prevention estimates only an 8.5% chance of survival if the disease is diagnosed at an advanced stage.
Colon cleansing (colonoscopy preparation) is a required prerequisite for successful colonoscopy. With the requirement to identify flat lesions (nonpolypoid colorectal neoplasms) there is now an even greater need for proper colon preparation. Flat or recessed lesions are much more difficult to spot than raised polyps with traditional colonoscopy, because their appearance is similar to normal tissue. Recent research has shown that these flat lesions may be more likely to be cancerous than polyps (Soetikno et al., “Prevalence of Nonpolypoid (Flat and Depressed) Colorectal Neoplasms in Asymptomatic and Symptomatic Adults,” J. Am. Med. Assoc. 299(9):1027-1035, 2008).
Colonoscopy preparation is commonly achieved with polyethylene glycol (PEG) solutions or oral sodium phosphate (NaP) solution or tablets. Both preparations have their limitations. Subject non-compliance because of an unpleasant taste and a necessary large fluid volume in combination with the drug ingestion has resulted in inadequate intake of PEG solution and poor colonoscopy preparation. Side effects of the PEG solution, such as bloating and nausea, are also common. Some subjects may tolerate the NaP solution or NaP tablets better than the PEG solution; however, the NaP solution has an acidic salty taste and, in addition to causing common gastrointestinal side effects, the use of NaP preparations has been associated with various fluid and electrolyte disturbances (Sharma et al., “Controlled study of pretreatment with magnesium citrate on the quality of colonoscopy preparation with polyethylene glycol electrolyte lavage solution,” Gastrointes Endosc 46(6):541-3, 1997; Caswell et al., “The time course and effect on serum electrolytes of oral sodium phosphates solution in healthy male and female volunteers,” Can J Clin Pharmacol 14(3):e260-74, 2007; Caswell et al., “Bowel preparation with oral sodium phosphate and renal disease,” Endoscopy. 38(8):852, 2006; Caswell et al., “Phosphate salt bowel preparation regimens alter perioperative acid-base and electrolyte balance,” Can J Anaesth 53(9):961, 2006).
L-glucose, the minor-image of the molecule D-glucose, cannot be metabolized by cells in the biochemical process known as glycolysis. L-glucose has been long recognized as a potential replacement for D-glucose because, like its enantiomer, it has similar organoleptic properties, i.e., sweetness and the bulk properties of D-glucose when used in food preparation.
Similarly, L-glucose has been studied for colon cleansing (colonoscopy preparation), which is a required prerequisite for successful colonoscopy. The use of L-glucose as an oral formulation for colon cleansing has been hampered by the dissolution properties of anhydrous L-glucose, the form that is currently manufactured. As such, when water is added to anhydrous L-glucose, clumping and slow dissolution are encountered. This fact has been a barrier to providing dry colon cleansing compositions to consumers for in home use. When faced with clumping and poor dissolution of L-glucose compositions, consumers may not receive the adequate dosage of L-glucose necessary to fully cleanse the colon prior to medical procedures because of the undissolved residue that remains behind in the container used to reconstitute the L-glucose containing composition.
In light of the limitations associated with currently available colonic cleansers, and the importance of proper colon preparation for colonoscopy, alternatives for colon cleansing are needed. For example, there is a need for new forms of L-glucose that are easily and more quickly dissolved in water. The compounds, compositions, methods, and kits disclosed herein address these needs and other needs.